Pulsed-Field Ablation With/Without Electrogram Mapping

NCT07541989 | Active Not Recruiting DMC

• 1 other identifier: PEAK-AF Study
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 10

Brief Summary

Pulsed field ablation (PFA) has demonstrated favorable safety and efficacy in atrial fibrillation ablation, particularly for pulmonary vein isolation (PVI). However, the optimal PFA-based ablation strategy for non-paroxysmal atrial fibrillation remains uncertain. In addition to anatomical lesion sets such as PVI and posterior wall isolation (PWI), Electrogram Mapping of Key Substrates may allow identification of residual arrhythmogenic areas that contribute to the maintenance of atrial fibrillation. In the investigators' previously completed single-center cohort study, adjunctive ablation targeting key substrates identified by electrogram mapping on top of PVI+PWI was feasible and associated with improved rhythm outcomes. This prospective multicenter randomized controlled study is designed to compare PFA-based PVI+PWI alone versus PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates in patients with non-paroxysmal atrial fibrillation, in order to evaluate the efficacy and safety of this strategy in a broader and more rigorous clinical setting.

Conditions

Non-paroxysmal Atrial Fibrillation

Keywords

non-paroxysmal atrial fibrillation; persistent atrial fibrillation; pulsed field ablation; catheter ablation; electrogram mapping; key substrate ablation; eletrogram-guided ablation

Outcome Measures

Primary Outcomes (2)

• freedom from any AF/AT

  The feasibility primary endpoint was defined as freedom from any AF/AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 3 months, 6 months, 12 months and 36 months respectively after the procedure.

  freedom from any AF/AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures.

• composite of major safety events

  The safety endpoint is a composite of major safety events including cardiac tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack (TIA), diaphragmatic paralysis, block, pericarditis, hemolysis, myocardial infarction, PV stenosis, atrioesophageal fistula, and death. The endpoint includes events occurring within 30 days of the index or reassessment procedures.

  adverse events occurring within 30 days of the index or reassessment procedures.

Secondary Outcomes (2)

• AF recurrence

  freedom from any AF at 3 months, 6 months, 12 months and 36 months respectively after the procedure

• AT recurrence

  freedom from any AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure

Other Outcomes (2)

• AF termination

  AF termination immediately during ablation, including AF terminated to sinus rhythm/atrial tachycardia

• difference of freedom from any AF/AT between patients with/without procedural AF termination

  freedom from any AF/AT at 3 months, 6 months, 12 months and 36 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures

Study Arms (2)

EGM

EXPERIMENTAL

PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates: Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI), followed by adjunctive ablation targeting key atrial substrates identified by predefined electrogram mapping criteria.

Procedure: PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates

PWI

ACTIVE COMPARATOR

Participants randomized to this arm will undergo pulsed-field ablation (PFA)-based pulmonary vein isolation (PVI) and posterior wall isolation (PWI) without adjunctive ablation guided by electrogram mapping of key substrates.

Procedure: PFA-based PVI+PWI alone

Interventions

PFA-based PVI+PWI alone PROCEDURE

Ablation will be performed using a pulsed-field ablation system. Participants in this arm will undergo standard pulmonary vein isolation and posterior wall isolation only, without additional substrate ablation guided by electrogram mapping.

PWI

PFA-based PVI+PWI plus adjunctive ablation guided by Electrogram Mapping of Key Substrates PROCEDURE

In the experimental arm, electrogram mapping will be performed before pulmonary vein isolation (PVI) and posterior wall isolation (PWI) to identify key atrial substrates for adjunctive ablation. Mapping may be conducted using machine learning-assisted electrogram mapping, operator-guided electrogram mapping, or a combination of both, based on the same predefined criteria for target identification. Electrogram analysis will then be performed to identify target regions with the following characteristics: 1)Spatial-temporal dispersion activation; 2)Short cycle length activity; 3)Focal activity. After completion of electrogram mapping and target identification, all participants in the experimental arm will undergo standard PFA-based PVI and PWI. Adjunctive pulsed-field ablation will subsequently be delivered to the electrogram-defined key substrates identified during the pre-ablation mapping phase.

EGM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with documented drug-resistant symptomatic persistent AF meeting all three of the following criteria:a. Patient is refractory or intolerant to at least one Class I/III antiarrhythmic agentb. ECG-documented episode of persistent AF lasting longer than 7 days c. Holter within 90 days of the Enrollment Date demonstrating 24 hours of continuous AF2. Patients who are ≥ 18 years and \<80 years 3. Patient participation requirements:a. Is willing and capable of providing Informed Consent to undergo study proceduresb. Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.

You may not qualify if:

• \. AF that is:a. Paroxysmal (longest AF episode \< 7days)b. Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes2. Left atrial anteroposterior diameter ≥ 60 mm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)3. Any of the following cardiac conditions:a. Clinically significant arrhythmias other than AF, AFL or ATb. NYHA Class IV CHFc. Atrial or ventricular septal defect closured. Atrial myxomae. History of congenital heart disease with any residual anatomic or conduction abnormality4. Any of the following within 3 months of enrollment:a. Myocardial infarctionb. Unstable anginac. Percutaneous coronary interventiond. Heart surgery (e.g. coronary artery bypass grafting, ventriculotomy, atriotomy)e. Heart failure hospitalizationf. Stroke or TIAg. Clinically significant bleedingh. Pericarditis or pericardial effusioni. Left atrial thrombus 5. History of blood clotting or bleeding abnormalities.6. Contraindication to, or unwillingness to use, systemic anticoagulation 7. Sensitivity to contrast media not controlled by premedication8. Women of childbearing potential who are pregnant, lactating or not using birth control9. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited toa. Body mass index (BMI) \> 40 transplantb. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspneac. Renal insufficiency with an estimated creatinine clearance \< 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant d. Active malignancy or history of treated cancer within 24 months of enrollmente. Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid refluxf. Clinically significant infectiong. Predicted life expectancy less than one year10. Current or anticipated enrollment in any other clinical study

Sponsors & Collaborators

• Xu Liu: lead
• Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine: collaborator

Study Sites (10)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430014, China

Location

Changshu Hospital of Traditional Chinese Medicine

Changshu, Jiangsu, 215516, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250001, China

Location

Jinan City People's Hospital

Jinan, Shandong, 271100, China

Location

Wenling Hospital of Traditional Chinese Medicine

Wenling, Zhejiang, 317500, China

Location

Yuhuan Second People's Hospital

Yuhuan, Zhejiang, 317600, China

Location

Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital

Shanghai, 200030, China

Location

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 21, 2026
• Study Start: September 30, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9); US (1)